DETAILED ACTION
This action is in response to applicant's amendments filed 07/28/25.
The examiner acknowledges the amendments to the claims.
Claims 1-20 are pending in this application.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot in view of the new grounds of rejection set forth below.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “closing mechanism” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 1 is objected to because of the following informalities: line 16 reads “the visual indicator” and should instead read as --the compression indicator--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4-6 and 13-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites “the insert, a spring, and a mechanism display that displays the amount of compression”. Claim 1, upon which Claim 4 depends, recites “an insert that, when compressed, displays a measured compression at a corresponding display”. It is unclear if the “mechanism display” in Claim 4 is referring to the previously recited “corresponding display” or an additional display. For examination purposes, “the mechanism display” limitation will be read as referring back to and further defining the “corresponding display”. Claim 5 is rejected due to its dependency on Claim 4.
Similarly, Claim 6 recites “the insert that includes load cells configured to send a measured force to a digital scale for display”. It is unclear whether or not the “digital scale for display” is referring to the previously recited “corresponding display” in Claim 1, upon which Claim 6 depends, or an additional display. For examination purposes, the “digital scale for display” will be read as referring back to and further defining the “corresponding display”.
Claim 13 recites “at least one disposable part”. However, Claim 12, upon which Claim 13 depends, recites “a disposable, removable cover”. It is unclear if “at least one disposable part” is referring to the previously recited “disposable, removable cover” or another disposable element. For examination purposes, the limitation in Claim 13 will be read as referring back to the previous recitation of “a disposable, removable cover”. Claims 14-15 are rejected due to their dependency on Claim 13.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lehman (U.S. Pat. No. 3,920,008) in view of Richardson et al., hereinafter “Richardson” (U.S. Pub. No. 2013/0319128).
Regarding claim 1, Lehman discloses an endoscopy support apparatus (concerning the limitation “endoscopy support apparatus”, the preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone - see In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951)), comprising:
a primary elastic wrap (“elastic primary band 14”; Figures 1-5, col. 2, lines 47-51) comprising a band of elastic material (Id.) sized for placement around a subject’s lower abdomen (band 14 is capable of being removably placed around the lower abdomen of a subject), and configured to apply a selected degree of constant pressure and support through contraction of the band of elastic material across the subject’s lower abdomen in order to facilitate passage of an endoscope ("configured to apply a selected degree of constant pressure and support through contraction of the band of elastic material across the subject’s lower abdomen in order to facilitate passage of an endoscope " constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner; the Office submits that the elastic primary band 14 meets the structural limitations of the claim, and is capable of compressing a patient’s lower abdomen, depending on the size of the patient and the tightness of the elastic band around the abdomen, thereby facilitating passage of an endoscope since the elastic band is capable of contracting across the patient’s lower abdomen);
a closing mechanism 16/18 (hook and loop material; col. 2, lines 58-68) provided at an end of the primary elastic wrap to secure the primary elastic wrap around the subject’s lower abdomen (by removably attaching the end 16 of the primary wrap to a second portion 18 of the primary wrap);
an elastic secondary strap 68 or 72 (segments 68, 72 are parts of “elastic band 56 and 58”; col. 4, lines 8-20) having a first, terminal end that attaches to the primary elastic wrap (Figure 1, col. 4, lines 12-16: segments are secured at stitching 64; it is noted that “attaches to” does not necessarily require being releasably attached, and therefore when the device is initially assembled the strap is attached to the elastic wrap) at a left portion of the primary elastic wrap (stitching 64 is at a left portion, or positioned to the left of central portion 38) and configured to stretch left to right across a front abdomen portion of the primary elastic wrap on an exterior side (see elastic straps 68, 72 move from a left side of a patient in Figure 3 to a right side of the patient in Figure 4) and to removably couple at a second, non-fixed end 84, 88 (hooks; col. 4, lines 40-49) to the primary elastic wrap at a non-fixed position (at 51, 53; Figure 4) to exert additional location specific compression to the subject’s lower abdomen, wherein an additional degree of compression through contraction is adjustable based on a position at which the second, non-fixed end of the elastic secondary strap is coupled to the primary elastic wrap (adjusting elastic secondary strap 68 or 72 from the left to the right side of the patient is capable of increasing the tension of the elastic secondary strap, and therefore exerts an additional targeted force to the portion of the abdomen underlying the strap via contraction of the elastic secondary strap when secured to the primary elastic wrap, wherein the degree of tension is adjustable based on how far to the right side the straps 68 or 72 are positioned at 51 or 53).
However, Lehman does not disclose a compression indicator that indicates an amount of compression generated on a subject’s colon or the subject’s lower abdomen, wherein the compression indicator includes at least one of:
a sensor positioned at the primary elastic wrap, wherein the sensor is configured to measure the amount of compression and illuminate a light at the endoscopy support apparatus when a compression threshold is measured,
one or more windows in the elastic secondary strap that align with one or more images on the primary elastic wrap to indicate the amount of compression,
an insert that, when compressed, displays a measured compression at a corresponding display, wherein the measured compression is measured as a force applied to the insert, or
a deformation mark on the exterior side of the primary elastic wrap that is configured to match a reference mark provided in accompanying instructions when a target compression is met.
In Figures 2-4B, Richardson teaches a support apparatus including a compression indicator including one or more windows 23 in a secondary strap 22 that align with one or more images 32, 34 on a primary wrap 21 to indicate the amount of compression ([0053]-[0057]).
It would have been obvious to one of ordinary skill at the time of invention to modify the elastic secondary strap and primary elastic wrap of Lehman to have one or more windows aligned with images as claimed, as taught by Richardson, in order to indicate to a user whether or not the applied compression is at a safe or unsafe level (Id.).
Claims 1-2 and 7-8 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lehman (U.S. Pat. No. 3,920,008) in view of Pienkowski et al., hereinafter “Pienkowski” (U.S. Pub. No. 2010/0234877).
Regarding claims 1-2, Lehman discloses the claimed invention, as discussed above, except for a compression indicator that indicates an amount of compression generated on a subject’s colon or the subject’s lower abdomen, wherein the compression indicator including a sensor positioned at the primary elastic wrap, wherein the sensor is configured to measure the amount of compression and illuminate a light at the endoscopy support apparatus when a compression threshold is measured,
Pienkowski teaches a support apparatus including a compression indicator that indicates an amount of compression generated on a subject’s body, wherein the compression indicator including a sensor (force sensor 50 in pressure pad 24 on wrap 12 Figures 1, 3, [0039]) positioned at a primary wrap 12, wherein the sensor is configured to measure the amount of compression and illuminate at light when a compression threshold is measured (Figure 1, [0039]-[0041]).
It would have been obvious to one of ordinary skill at the time of invention before to modify Lehman with a compression indicator/sensor as claimed, as taught by Pienkowski, in order to notify the user of the proper amount of compression force needed during adjustment (Id.).
Regarding claims 1, 7-8, Lehman discloses the claimed invention, as discussed above, except for a compression indicator that indicates an amount of compression generated on a subject’s colon or the subject’s lower abdomen, wherein the compression indicator including an insert that, when compressed, displays a measured compression at a corresponding display, wherein the measured compression is measured as a force applied to the insert, wherein the compression indicator displays a binary output or ternary output that indicates at least two of: a first indication that an applied compression is below a target amount of compression, a second indication that the applied compression is above the target amount of compression, or a third indication that the target amount of compression is applied, wherein the compression indicator further includes a battery.
Pienkowski teaches a support apparatus including a compression indicator
that indicates an amount of compression generated on a subject’s body, wherein the compression indicator including an insert (pressure pad 24; Figure 1) that, when compressed, displays a measured compression at a corresponding display (LED display 32; Figure 4, [0034]), wherein the measured compression is measured as a force applied to the insert ([0039]-[0041]), wherein the compression indicator displays a binary output or ternary output that indicates at least two of: a first indication that an applied compression is below a target amount of compression (Id.; LED blinks red), a second indication that the applied compression is above the target amount of compression, or a third indication that the target amount of compression is applied (Id.; LED illuminates green), wherein the compression indicator further includes a battery 44 (Figure 3, [0034]).
It would have been obvious to one of ordinary skill at the time of invention before to modify Lehman with a compression indicator, insert, outputs and battery as claimed, as taught by Pienkowski, in order provide a notification system for the user of the proper amount of compression force needed during adjustment (Id.).
Claim 3 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lehman (U.S. Pat. No. 3,920,008) in view of Richardson (U.S. Pub. No. 2013/0319128), as applied to claim 1 above, and further in view of Smith (U.S. Pub. No. 2014/0142616).
Regarding claim 3, Lehman as modified teaches the claimed invention, as discussed above, except for the compression indicator includes multiple windows in the elastic secondary strap that align with multiple images on the primary elastic wrap to indicate the amount of compression.
In Figures 4-7, [0070]-[0072] Smith teaches a support apparatus including a compression indicator with multiple windows 72 that align with multiple images 66, 67 to indicate the amount of compression.
It would have been obvious to one of ordinary skill at the time of invention before to modify Lehman and Richardson with multiple windows aligning with multiple images, as taught by Smith, to more precisely notify the user of the amount of compression
needed during adjustment (Id.).
Claims 1, 4-6 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lehman (U.S. Pat. No. 3,920,008) in view of Pienkowski (U.S. Pub. No. 2010/0234877) and Khorassani Zadeh (U.S. Pub. No. 2007/0270727).
Regarding claims 1 and 4-5, Lehman discloses the claimed invention, as discussed above, except for a compression indicator that indicates an amount of compression generated on a subject’s colon or the subject’s lower abdomen, wherein the compression indicator including an insert that, when compressed, displays a measured compression at a corresponding display, wherein the measured compression is measured as a force applied to the insert, wherein the compression indicator includes the insert, a spring, and a mechanism display that displays the amount of compression based on the force applied to the spring, and further comprising a window through which the mechanical display is viewable.
Pienkowski teaches a compression indicator that indicates an amount of compression generated on a subject’s body, wherein the compression indicator includes an insert (Figure 1; pressure pad 24) that measures a compression, wherein the measured compression is measured as a force applied to the insert (via force sensor 50; [0039]-[0041]).
Furthermore, Khorassani Zadeh teaches a compression indicator including an insert 14 (Figures 1-2) that when compressed, displays a measured compression at a corresponding display 40, wherein the compression indicator further includes a spring (at 46; [0094]), and the corresponding display including a mechanism display 40 that displays the amount of compression based on the force applied to the spring (Id.), and further comprising a window through which the mechanical display is viewable (Figure 1; pressure reading can be seen in a window within housing of gauge 40).
It would have been obvious to one of ordinary skill at the time of invention before to modify Lehman with a compression indicator including an insert, spring, and display as claimed, as taught by Pienkowski and Khorassani Zadeh, to provide a readily ascertainable reading of the amount of pressure being applied to a user (Khorassani Zadeh; [0094])
Regarding claims 1 and 6, Lehman discloses the claimed invention, as discussed above, except for a compression indicator that indicates an amount of compression generated on a subject’s colon or the subject’s lower abdomen, wherein the compression indicator includes an insert that, when compressed, displays a measured compression at a corresponding display, wherein the measured compression is measured as a force applied to the insert, wherein the compression indicator includes the insert that includes load cells configured to send a measured force to a digital scale for display.
Pienkowski teaches a compression indicator that indicates an amount of compression generated on a subject’s body, wherein the compression indicator includes an insert (Figure 1; pressure pad 24) that measures a compression, wherein the measured compression is measured as a force applied to the insert (via force sensor 50; [0039]-[0041]), wherein the compression indicator includes the insert that includes load cell (via sensor 50).
Furthermore, Khorassani Zadeh teaches a compression indicator including an insert 14 (Figures 1-2) that when compressed, displays a measured compression at a corresponding display 40. Khorassani Zadeh further teaches that a pressure readout can be accomplished with a digital scale, allowing the patient to monitor the applied pressure ([0091]).
It would have been obvious to one of ordinary skill at the time of invention before to modify Lehman with a compression indicator including an insert, a load cell, and digital scale, as taught by Pienkowski and Khorassani Zadeh, to provide a readily ascertainable reading of the amount of pressure being applied to a user (Khorassani Zadeh; [0094]). Although the references to do not teach more than one load cell, a skilled artisan would acknowledge that having additional load cells may result in a more accurate pressure readout, and since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claims 1 and 9 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lehman (U.S. Pat. No. 3,920,008) in view of Smith (U.S. Pub. No. 2014/0142616).
Regarding claims 1 and 9, Lehman as modified teaches the claimed invention, as discussed above, except for a compression indicator that indicates an amount of compression generated on a subject’s colon or the subject’s lower abdomen, wherein the compression indicator including a deformation mark on the exterior side of the primary elastic wrap that is configured to match a reference mark provided in accompanying instructions when a target compression is met, wherein the compression indicator includes the deformation mark on the exterior side of the primary elastic wrap that is configured to match the reference mark provided in the accompanying instructions when the target compression is met.
Smith teaches a support apparatus having a deformation mark 65 on an exterior side of a primary elastic wrap 60 ([0017], [0072]; Figure 4) that is configured to match a reference mark when a target compression is met (Id.; 65 may include visual indicia “GO” and “NOGO” or other suitable words, wherein the words are reference marks that convey when the wrap is applying the appropriate amount of pressure or not), wherein the compression indicator includes the deformation mark on an exterior side of the primary elastic wrap that is configured to match the reference mark when the target compression is met (Id.).
It would have been obvious to one of ordinary skill at the time of invention before to modify Lehman with a deformation mark matching a reference mark as claimed, as taught by Smith, to more clearly notify the user of the amount of compression needed during adjustment (Id.). Although the reference mark is not expressly provided in accompanying instructions, a skilled artisan would understand that including instructions with “GO” and “NOGO” or other words suitable to convey when the wrap is applying the appropriate amount of pressure would have been obvious to provide user guidance and prevent user error.
Claim 10 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lehman (U.S. Pat. No. 3,920,008) in view of Skwor et al., hereinafter “Skwor” (U.S. Pat. No. 5,042,464).
Regarding claim 10, Lehman discloses the claimed invention, as discussed above, except for the primary elastic wrap comprises an inner layer of latex-free neoprene and an exterior layer of polyester or nylon.
Skwor teaches in col. 5, lines 22-28 a support apparatus including an inner layer of neoprene 52 and an exterior layer 50 of nylon.
It would have been obvious to one of ordinary skill at the time of invention to modify Lehman with neoprene and nylon as claimed, as taught by Skwor, since doing so would provide an inner layer that acts as a moisture barrier and an outer layer that does not irritate a user’s skin. Although Skwor does not expressly teach the neoprene layer being latex-free, one of ordinary skill in the art would acknowledge that it is commonly known that individuals may be allergic to latex, and therefore a latex-free neoprene would be suitable for more users to prevent allergic reactions, and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use.
Claim 11 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lehman (U.S. Pat. No. 3,920,008) in view of Conkle (U.S. Pub. No. 2007/0044211).
Regarding claim 11, Lehman discloses the claimed invention, as discussed above, except for further comprising serge stitching along edges of the primary elastic wrap that increases resistance of the primary elastic wrap to roll-up when applied.
Conkle teaches in [0009], [0011] serge stitching along edges of a support apparatus, which would be capable of increasing resistance of the support apparatus to roll-up.
It would have been obvious to one of ordinary skill at the time of invention before to modify Lehman with serge stitching as claimed, as taught by Conkle, since it is a type of stitch old and well known in the art for reinforcing seams.
Claims 12-15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lehman (U.S. Pat. No. 3,920,008) in view of Pickett et al., hereinafter “Pickett” (U.S. Pat. No. 7,074,177).
Regarding claims 12-15, Lehman discloses the claimed invention, as discussed above, including at least one re-usable part configured for a finite number of uses (due to wear and tear, the device of Lehman may be used a finite number of times until it is no longer operable), except for a disposable, removable cover for a portion of the endoscopy support apparatus, wherein the endoscopy support apparatus includes a combination of at least one re-usable part and at least one disposable part, and wherein the at least one disposable part includes a feature that indicates whether the endoscopy support apparatus has been previously used, wherein the feature changes one or more of color, shape, size, or composition after use.
Pickett teaches a support apparatus having a disposable, removable cover (“wax paper-type protector; col. 14, lines 5-11). The feature that indicates whether the support apparatus has been previously used can include a change in shape after use, since the wax, paper-type material may be easily deformed by a user’s fingers when removed from the support apparatus.
It would have been obvious to one of ordinary skill at the time of invention before to modify Lehman with a disposable, removable cover as claimed, as taught by Pickett, in order to use as a protectant before securing the device to the body (Id.). In combination with Lehman, the endoscopy support apparatus would have a combination of one re-usable part and at least one disposable part.
Claim 16 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lehman (U.S. Pat. No. 3,920,008) in view of Herz et al., hereinafter “Herz” (U.S. Pub. No. 2003/0069528).
Regarding claim 16, Lehman discloses the claimed invention, as discussed above, including the second, non-fixed end of the elastic secondary strap on the primary elastic wrap being capable of providing different, targeted compression to a splenic flexure, a transverse colon, and a hepatic flexure (depending on the orientation of the elastic secondary strap the device of Lehman may provide different target compression to these various areas of a user’s body), except for the first, terminal end of the elastic secondary strap removably couples to primary elastic wrap via a hook and loop fastener, wherein different orientations of the elastic secondary strap based on different positions of both the first, terminal end.
Herz teaches a support apparatus with a strap having a first, terminal end that removably couples to a primary wrap via a hook and loop fastener, as well as a second, non-fixed end that is similarly removably coupled ([0079], [0089]; both ends of a strap may be variably positionable on a wrap by virtue of its VELCRO® surfaces).
It would have been obvious to one of ordinary skill at the time of invention before to modify Lehman such that the first, terminal end is removably coupled to the primary wrap as claimed, as taught by Hertz, in order to facilitate adjusting the pressure applied by the strap (Id.).
Claims 1, 17-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lehman (U.S. Pat. No. 3,920,008) in view of Pienkowski (U.S. Pub. No. 2010/0234877) and Khorassani Zadeh (U.S. Pub. No. 2007/0270727), and Brown (U.S. Pub. No. 2014/0135819).
Regarding claims 1, 17-19, Lehman discloses the claimed invention, as discussed above, except for a compression indicator that indicates an amount of compression generated on a subject’s colon or the subject’s lower abdomen, wherein the compression indicator includes an insert that when compressed, displays a measured compression at a corresponding display, wherein the measured compression is measured as a force applied to the insert, and wherein the insert comprises one of:
a semi-flexible plastic, a semi-flexible silicone composite, or an inflatable plastic,
wherein the insert further comprises one or more of paper, rubber, neoprene, or fabric surrounding an inner material having an increased hardness, wherein the insert comprises a shape having one or more of: tapering edges, a football shape, a semi-hemispherical shape, or a cylindrical shape.
Pienkowski teaches a compression indicator that indicates an amount of compression generated on a subject’s body, wherein the compression indicator includes an insert (Figure 1; pressure pad 24) that measures a compression, wherein the measured compression is measured as a force applied to the insert (via force sensor 50; [0039]-[0041]).
Furthermore, Khorassani Zadeh teaches a compression indicator including an insert 14 (Figures 1-2) that when compressed, displays a measured compression at a corresponding display 40.
It would have been obvious to one of ordinary skill at the time of invention before to modify Lehman with a compression indicator including an insert, as taught by Pienkowski and Khorassani Zadeh, to provide a readily ascertainable reading of the amount of pressure being applied (Khorassani Zadeh; [0094])
Additionally, Brown teaches in Figures 5-6 a support apparatus having an insert 14/16, wherein the insert comprises a semi-flexible plastic 14 ([0037]), and includes a fabric 16 surrounding an inner material 14 having an increased hardness ([0035]-[0036]), and the insert comprising a shape having a cylindrical shape 14 ([0039]).
It would have been obvious to one of ordinary skill at the time of invention to have the insert be made of plastic material and surrounded by plastic and a cylindrical shape as claimed, as taught by Brown, in order to facilitate applying high pressure to the body of a user (Brown; [0035]).
Claims 1, 17, 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lehman (U.S. Pat. No. 3,920,008) in view of Pienkowski (U.S. Pub. No. 2010/0234877), Lee (U.S. Pub. No. 2011/0093003), and McEwen (U.S. Patent No. 5,741,295).
Regarding claims 1, 17, 20, Lehman discloses the claimed invention, as discussed above, except for a compression indicator that indicates an amount of compression generated on a subject’s colon or the subject’s lower abdomen, wherein the compression indicator includes an insert that when compressed, displays a measured compression at a corresponding display, wherein the measured compression is measured as a force applied to the insert, and wherein the insert comprises one of:
a semi-flexible plastic, a semi-flexible silicone composite, or an inflatable plastic, wherein the insert includes an inflatable bladder having a tube for connection to a pressure measurement device, wherein the amount of applied compression is displayed based on a difference between a baseline value of pressure applied to the inflatable bladder prior to application of compression via the endoscopy support apparatus and a measured pressure of the inflatable bladder after the application of the compression via the endoscopy support apparatus.
Pienkowski teaches a compression indicator that indicates an amount of compression generated on a subject’s body, wherein the compression indicator includes an insert (Figure 1; pressure pad 24) that measures a compression, wherein the measured compression is measured as a force applied to the insert (via force sensor 50; [0039]-[0041]).
It would have been obvious to one of ordinary skill at the time of invention before to modify Lehman with a compression indicator/insert as claimed, as taught by Pienkowski, in order to notify the user of the proper amount of compression force needed during adjustment (Id.).
Furthermore, Lee teaches a compression indicator including an inflatable insert or bladder 30 (Figures 1, 4-4A; [0039]) that when compressed, displays a measured compression at a corresponding display 50 ([0042]). Lee teaches that an inflatable bladder may be made of plastic ([0039]). The inflatable bladder 30 has a tube 32 (Figure 4A) for connection to a pressure measurement device ([0048]).
It would have been obvious to one of ordinary skill at the time of invention before to modify Lehman as modified with an inflatable insert as claimed, as taught by Lee, since doing so would be substituting one known insert for another which would yield predictable results, namely applying a desired amount of pressure to a patient’s body. See MPEP 2143.
Additionally, Lee acknowledges displaying an actual amount of applied compression to a user (via a processor 200; [0053]-[0054]) rather than simply displaying a baseline value of pressure measured in the inflatable bladder..
McEwen teaches in col. 1, lines 43-47 and col. 2, lines 9-23 that in support apparatuses there are differences and discrepancies between an inflation pressure merely measured in the apparatus and the pressure or compression that is actually applied to a user, and therefore there is a difference between a baseline value of pressure applied to the apparatus prior to application of compression via the support apparatus and a measured pressure of the apparatus after the application of the compression.
It would have been obvious to one of ordinary skill before the effective filing date to modify Lehman as modified by having the amount of applied compression displayed based on a difference between a baseline value of pressure applied to the inflatable bladder prior to application of compression via the endoscopy support apparatus and a measured pressure of the inflatable bladder after the application of the compression via the endoscopy support apparatus, as taught by McEwen and Lee, in order to more accurately convey to a user the actual amount of applied pressure (Id.) and therefore assess whether an effective amount of compression is being applied.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 12, 15-18 of U.S. Patent No. 11,701,286 in view of Richardson (U.S. Pub. No. 2013/0319128), Pienkowski (U.S. Pub. No. 2010/0234877), Smith (U.S. Pub. No. 2014/0142616), Khorassani Zadeh (U.S. Pub. No. 2007/0270727), Skwor (U.S. Pat. No. 5,042,464), Conkle (U.S. Pub. No. 2007/0044211), Pickett (U.S. Pat. No. 7,074,177), Herz (U.S. Pub. No. 2003/0069528), Brown (U.S. Pub. No. 2014/0135819), Lee (U.S. Pub. No. 2011/0093003), and McEwen (U.S. Patent No. 5,741,295). Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that elements in the applications are to be found in the claims including a primary elastic wrap comprising a band of elastic material sized for placement around a subject’s lower abdomen and configured to apply a selected degree of constant pressure and support through contraction of the band of elastic material in order to facilitate passage of an endoscope, a closing mechanism provided at an end of the primary elastic wrap to secure the primary elastic wrap around the subject’s lower abdomen, an elastic secondary strap having a first, terminal end attaches to the primary elastic wrap at a left portion of the primary elastic wrap and configured to stretch left to right across a front abdomen portion of the primary elastic wrap on an exterior side and to removably couple at a second, non-fixed end to the primary elastic wrap at a non-fixed position to exert additional location specific compression to the subject's lower abdomen, wherein an additional degree of compression through contraction is adjustable based on a position at which the second, non-fixed end of the elastic secondary strap is coupled to the primary elastic wrap. However, features that are merely obvious, as discussed above by Richardson, Pienkowski, Smith, Khorassani Zadeh, Skwor, Conkle, Pickett, Herz, Brown, Lee and McEwen are lacking in the patent claims and would have been obvious to modify the patent claims with said features for the same reasons described above.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 of U.S. Patent No. 10,441,222 in view of Lehman (U.S. Pat. No. 3,920,008) and Richardson (U.S. Pub. No. 2013/0319128), Pienkowski (U.S. Pub. No. 2010/0234877), Smith (U.S. Pub. No. 2014/0142616), Khorassani Zadeh (U.S. Pub. No. 2007/0270727), Skwor (U.S. Pat. No. 5,042,464), Conkle (U.S. Pub. No. 2007/0044211), Pickett (U.S. Pat. No. 7,047,177), Herz (U.S. Pub. No. 2003/0069528), Brown (U.S. Pub. No. 2014/0135819), Lee (U.S. Pub. No. 2011/0093003), and McEwen (U.S. Patent No. 5,741,295).
Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that elements of the application claim are to be found in the patent claim including a primary elastic wrap comprising a band of elastic material configured to apply a selected degree of constant pressure and support through contraction of the band of elastic material in order to facilitate passage of an endoscope (in the wrapping and securing steps of patent claim 1), a secondary strap having a first, terminal end fixed to a left portion of the primary elastic wrap and configured to stretch left to right across a front abdomen portion of the primary wrap on an exterior side and to removably couple at a second, non-fixed end to the primary elastic wrap at a non-fixed position to exert additional location specific compression to the subject’s lower abdomen, wherein an additional degree of compression is adjustable based on a position at which the second, non-fixed end of the secondary strap is coupled to the primary elastic strap (in the adjusting compression step of patent claim 1).
The difference lies in the fact that the application claims add features that are merely obvious such as a closing mechanism provided at an end of the primary elastic wrap to secure the primary elastic wrap around the subject’s lower abdomen, and the secondary strap being elastic, wherein an additional degree of compression through contraction is adjustable based on a position at which the second, non-fixed end of the elastic secondary strap is coupled to the primary elastic wrap.
Lehman teaches a closing mechanism 16/18 (hook and loop material; col. 2, lines 58-68) provided at an end of the primary elastic wrap to secure the primary elastic wrap around the subject’s lower abdomen (by removably attaching the end 16 of the primary wrap to a second portion 18 of the primary wrap); and an elastic secondary strap 68 or 72 (segments 68, 72 are parts of “elastic band 56 and 58”; col. 4, lines 8-20) having a first, terminal end that attaches to the primary elastic wrap (Figure 1, col. 4, lines 12-16: segments are secured at stitching 64) at a left portion of the primary elastic wrap (stitching 64 is at a left portion, or positioned to the left of central portion 38) and configured to stretch left to right across a front abdomen portion of the primary elastic wrap on an exterior side (see elastic straps 68, 72 move from a left side of a patient in Figure 3 to a right side of the patient in Figure 4) and to removably couple at a second, non-fixed end 84, 88 (hooks; col. 4, lines 40-49) to the primary elastic wrap at a non-fixed position (at 51, 53; Figure 4) to exert additional location specific compression to the subject’s lower abdomen, wherein an additional degree of compression through contraction is adjustable based on a position at which the second, non-fixed end of the elastic secondary strap is coupled to the primary elastic wrap (adjusting elastic secondary strap 68 or 72 from the left to the right side of the patient is capable of increasing the tension of the elastic secondary strap, and therefore exerts an additional targeted force to the portion of the abdomen underlying the strap via contraction of the elastic secondary strap when secured to the primary elastic wrap, wherein the degree of tension is adjustable based on how far to the right side the straps 68 or 72 are positioned at 51 or 53).
It would have been obvious to one of ordinary skill at the time of invention to modify the patent claim such that there is a closing mechanism as claimed, and that the secondary strap is elastic, as taught by Lehman, in order to ensure securement of the primary elastic wrap around a patient’s body, as well as to provide an obvious material for providing a degree of compression through contraction since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use.
Other features that are merely obvious were discussed above by Richardson, Pienkowski, Smith, Khorassani Zadeh, Skwor, Conkle, Pickett, Herz, Brown, Lee and McEwen are lacking in the patent claims and would have been obvious to modify the patent claims with said features for the same reasons described above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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